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CZ20023908A3 - Protéza pro náhradu kyčelního kloubu - Google Patents

Protéza pro náhradu kyčelního kloubu Download PDF

Info

Publication number
CZ20023908A3
CZ20023908A3 CZ20023908A CZ20023908A CZ20023908A3 CZ 20023908 A3 CZ20023908 A3 CZ 20023908A3 CZ 20023908 A CZ20023908 A CZ 20023908A CZ 20023908 A CZ20023908 A CZ 20023908A CZ 20023908 A3 CZ20023908 A3 CZ 20023908A3
Authority
CZ
Czechia
Prior art keywords
head
femoral
insert
prosthesis
acetabular
Prior art date
Application number
CZ20023908A
Other languages
English (en)
Inventor
Gordon William Blunn
Sarah Kathryn Muirhead-All-Wood
Original Assignee
University College London
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University College London filed Critical University College London
Publication of CZ20023908A3 publication Critical patent/CZ20023908A3/cs

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
    • A61L27/28—Materials for coating prostheses
    • A61L27/30—Inorganic materials
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30721—Accessories
    • A61F2/30724—Spacers for centering an implant in a bone cavity, e.g. in a cement-receiving cavity
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2/4637—Special tools for implanting artificial joints for connecting or disconnecting two parts of a prosthesis
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30108—Shapes
    • A61F2002/30199—Three-dimensional shapes
    • A61F2002/30205—Three-dimensional shapes conical
    • A61F2002/30217—Three-dimensional shapes conical hollow cones, e.g. tubular-like cones
    • A—HUMAN NECESSITIES
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
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    • A61F2002/30316—The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
    • A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
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    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2002/30448—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives
    • A61F2002/30449—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using adhesives the adhesive being cement
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    • A61F2/02—Prostheses implantable into the body
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    • A61L2430/00—Materials or treatment for tissue regeneration
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Description

Ρ&Τ&ΤΆ Ρ&ο MS/MLAbU ítyc&frWO £ίον£θ lnedu iiaunýdTptMul iů pro· protézy kyčelního kloubu
Oblast techniky
Vynález se týká postupu obnovy protézy pro náhradu kyčelního kloubu a zdokonalení prvků této protézy.
Dosavadní stav techniky
Nejobvyklejší metodou léčby kyčelního kloubu postiženého artrózou je úplná náhrada kyčelního kloubu. Tento postup spočívá v připevnění acetabulární komponenty k pánevní kosti v místě přirozené kloubní jamky a připevnění femorální komponenty k proximálnímu konci stehenní kosti užitím intramedulámího dříku, což se provádí po resekci postižené stehenní kosti. Standardně lze obě komponenty protézy stmelit na daném místě užitím akrylového kostního cementu nebo lze zejména v případě femorálního dříku je možno vycházet z přirozeného připojení nebo vrůstání kostí, které zajistí k upevnění k přirozené kostí. Femorální komponenta obsahuje femorální hlavici s kulovou částí v kloubním spojení s vložkou uzpůsobenou pro nasednutí do acetabulární komponenty. Vložka se běžně zhotovuje z polyethylenového polymeru o velmi velké molekulární hmotnosti a v některých konstrukcích je hlavice stehenní kosti vyměnitelná, takže operatér může vybrat pro konkrétního pacienta hlavici vhodné velikosti.
V řadě případů přestává kloubní náhrada po čase fungovat. Někdy je příčinou aseptické uvolnění. Aseptické uvolnění má za následek resorpci kosti na rozhraní mezi kostí a protézou a následné zformování měkké tkáně vedoucí k nestabilní fixací. Aseptické uvolnění může být vyvoláno částicemi opotřebené hmoty vzniklými pohybem povrchů s kloubním spojením. Těmito částicemi opotřebené hmoty mohou být malé polyethylenové částice menší než 1 mikron vznikající z polyethylenové vložky.
Stupeň opotřebení polyethylenových vložek bývá větší u malých femorálních hlavic, které se používají u pacientů malého vzrůstu včetně dětí.
Důvodem je větší zátěž na povrchy s kloubním spojením a vyšší rychlosti pronikání femorální hlavice do polyethylenových kloubních jamek U takových pacientů existuje velká pravděpodobnost neúspěchu s nutností jedné nebo více revizních operací nutných k náhradě původní protézy.
V běžné praxi, pokud se nevyskytlo aseptické uvolnění, zahrnují revizní operace náhradu aeetabulámí vložky nebo hlavice stehenní kosti.
Tímto se sice stav krátkodobě zlepší, ale neřeší se možnost recidivy z dlouhodobého hlediska.
Podstata vynálezu
Jeden aspekt vynálezu se zabývá metodou obnovení náhrady kyčelního kloubu obsahující dřík, hlavici stehenní kosti a aeetabulámí pouzdro mající polyethylenovou vložku, u níž došlo k opotřebení, přičemž uvedený postup zahrnuje odstranění vložky a její náhradu vložkou s tvrdým povrchem, kde vložka je vhodné vytvarována pro hlavici stehenní kosti, a připevnění vložky k pouzdru. Vložka má přednostně tvrdý povrch odolný proti opotřebení pro kontakt s hlavicí kosti stehenní. Mezi vhodné materiály patří kovy a keramika nebo smíšené materiály. Tvrdá povrchová vložka může být zhotovena např. ze slitinu kobaltu a chrómu nebo keramického materiálu, jako je oxid hlinitý a nebo oxid zirkonia, případně ze skleněného materiálu.
Hlavice stehenní kosti může být rovněž nahrazena substituční hlavicí vytvarovanou tak, aby byla vhodná pro kovovou vložku. To může být žádoucí, protože po odstranění polyethylenové vložky je prostor v acetabulámím pouzdře obecně různý. Aby bylo možno vhodně provést náhradu hlavic stehenní kosti různé velikosti, může femorální komponenta obsahovat modulární hlavicí upevněnou ke stopce např. prostřednictvím kuželovitého prvku. Hlavice stehenní kosti může obsahovat kuželovitou jamku a pro přizpůsobení se modulárním hlavicím s jamkami s různým zešikmením lze mezi femorální dřík a modulární hlavici vložit modulární manžetu.
Kovová vložka pro náhradu se vhodně upevní k acetabulámímu pouzdru kostním cementem, např. akrylovým kostním cementem.
Výše uvedený proces umožňuje opravu nebo obnovu protézy pro náhradu kyčelního kloubu bez narušení původního upevnění acetabulárních komponent ke kosti pacienta.
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Za některých okolností může být žádoucí přilepit kovovou vložku k pouzdru přes středovou mezivložku např. z polyethylenu. To je třeba např. tehdy, nelze-li prostor v pouzdru snadno přizpůsobit volbou hlavice stehenní kosti vhodné velikosti. Vložka může být přilepena přímo přes stávající polyethylenovou vložku, zejména je-li v relativně dobrém stavu. Za jiných okolností lze do pouzdra umístit novou středovou vložku ještě před připevněním kovové vložky nebo může být středová vložka součástí tvrdé povrchové vložky např. po provedení lamínace nebo jiném způsobu připevnění k povrchu, který se má dotýkat acetabulámího pouzdra.
V procesu výměny se přednostně využívá stávajících prvků ležících mimo pouzdro již zhotovených výrobci ortopedického vybavení nebo se používají modulární zařízení vyrobená konkrétně pro účely vynálezu.
Existuje řada různých kuželovitých prvků, které ortopedické společnosti používají pro spojování modulární hlavice a krčku stehenní kosti. V těchto případech je někdy nutné přizpůsobit zešikmení, do něhož nasedá hlavice. K tomu lze použít kovovou manžetu, tvarově vhodnou ke kuželovitému prvku femorálního dříku a uzpůsobenou kuželovitému prvku v kloubní jamce náhrady hlavice stehenní kosti.
Užitím tohoto druhu manžety by mohla být uzpůsobena pro použití s různými hlavicemi stehenní kosti celá řada různých dříků kyčelního kloubu s různým zešikmením. Je možno vyrobit řadu různých manžet pro nejrůznější kuželovité prvky, užívané rozličnými výrobci ortopedických pomůcek. Jednou ze speciálních výhod protézy podle vynálezu je to, že brání opotřebení polyethylenových vložek, k němuž dochází u pacientů s malou postavou. Z dlouhodobého hlediska by tento proces šetřil náklady, protože by snižoval množství revizních procedur, které tito pacienti potřebují.
Přehled obrázků na výkresech
Vynález je ilustrován doprovodnými neformálními výkresy.
Obrázek 1 je perspektivní znázornění femorálního dříku v kloubním spojení s opotřebovanou acetabulární polyethylenovou vložkou o velmi vysoké molekulární hmotnosti.
Obrázek 2 je obdobné znázornění, ale ukazující v rozvinuté podobě hlavici stehenní kosti na femorálním dříku a kovovou vložku upevněnou na acetabulární pouzdro.
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Obrázek 3 znázorňuje hlavici stehenní kosti zavedenou do acetabulámího pouzdra vybaveného přilepenou kovovou vložkou.
Příklady provedeni vynálezu
Acetabulární pouzdro 1 je připevněno k pánevní kosti 2 bezcementovou fixací, kdy je stimulován růst kosti až k pouzdru 1. Toto lze provést např. nasazením pouzdra do tvarované jamky v pánevní kosti a zformováním povrchu, který je v kontaktu s kostí pomocí mikrozářezů a je pokryt hydroxyapatitem. Vnitřní povrch acetabulámího pouzdra podpírá polyethylenovou vložku o velmi vysoké molekulární hmotnosti 3. Femorální komponenta obsahující femorální dřík 4 nese hlavici stehenní kosti 5, která je v kloubním spojení s acetabuiámím pouzdrem. Jak lze vidět na obrázku, polyethylenová vložka se opotřebovala nerovnoměrné a v různých částech pouzdra má různou tloušťku.
Obrázek 2 znázorňuje zdokonalení, které přináší vynález, v němž je acetabulární pouzdro 1 pevně ukotveno v jamce 2 v pánevní kosti. Aby se však v tomto případě předešlo nerovnoměrnému opotřebení, je do pouzdra 1 vrstvou akrylového kostního cementu 7 vlepena kovová vložka 6. Aby bylo možno se přizpůsobit dalšímu prostoru v pouzdře, vytváří vrstva polyethylenu 8 středový meziprvek mezi vrstvou cementu a kovovou vložkou.
V případě kovových vložek je žádoucí, aby byla hlavice stehenní kosti 5 pevně nasazena s omezenou tolerancí v jamce tvaru polokoule, tvořené kovovou vložkou 6. Vynález tedy v rámci svého rozsahu poskytuje modulární hlavice 5 femorálního dříku 4, které jsou připevněny prostřednictvím kuželovitého prvku ke krčku stehenní kosti 9. Pro přizpůsobení se různému zešikmení v jamce hlavice stehenní kosti a zešikmení různého stupně 11 na femorálním dříku lze použít manžetu 12 se zešikmenými povrchy, které jsou na vnějším kruhovém povrchu různé.
Obrázek 3 ukazuje variaci na uspořádání znázorněné na obrázku 2, v němž je kovová vložka 6 přímo přilepena kostním cementem 7 k pouzdru 1.

Claims (5)

PATENTOVÉ NÁROKY (upravené) • · ·«··
1. Protéza pro náhradu kyčelního kloubu pro použití při obnově stávající protézy, přičemž uvedená náhradní protéza se vyznačuje tím, že zahrnuje:
sférickou hlavicí stehenní kosti (5) s kuželovitým otvorem, femorální dřík (4) s kuželovitým krčkem (9) uzpůsobeným pro nasednutí do kuželovitého otvoru v hlavici femorální kosti (5), manžetu (12) umístěnou mezi kuželovitý krček (9) a otvor v hlavici stehenní kosti (5) a acetabulární pouzdro (1) pro umístění v jamce pánevní kosti, přičemž pouzdro (1) má vložku s tvrdým povrchem (6) zhotovenou z kovu nebo keramického materiálu pro nasazení hlavice stehenní kosti (5).
2. Protéza podle nároku 1, vyznačující tím, že vložka (6) je připevněna k pouzdru (1) vrstvou (7) kostního cementu.
3. Protéza podle nároku 1, vyznačující tím, že vložka (6) je připevněna k pouzdru (1) vrstvou (7) kostního cementu a středovým meziprvkem (8).
4. Protéza podle nároku 3, vyznačující tím, že středový meziprvek (8) je zhotoven z plastu.
5. Stavebnicová sestava prvků pro použití u protézy podle jednoho nebo několika předcházejících nároků, přičemž uvedená stavebnicová sestava prvků se vyznačuje tím, že obsahuje modulární vyměnitelnou sférickou hlavicí stehenní kostí (5) s kuželovitým otvorem, manžetu (12) pro umístění do otvoru v hlavici (5) uzpůsobenou pro upevnění hlavice ke kuželovitému krčku (9) femorálního dříku a acetabulární pouzdro (1) s vložkou s tvrdým povrchem (6) z kovového nebo keramického materiálu uzpůsobené pro nasazení hlavice stehenní kosti (5).
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